AZIYO IFU-0006 ViBone Instructions
- June 5, 2024
- AZIYO
Table of Contents
AZIYO IFU-0006 ViBone
THIS PRODUCT IS MANUFACTURED FROM DONATED HUMAN TISSUE, RECOVERED FROM A SINGLE HUMAN DONOR WITH DOCUMENTED AUTHORIZATION FOR DONATION AND RECOVERY. THE TISSUE IS RECOVERED AND SUPPLIED FROM U.S. TISSUE BANKS ONLY. THE RECOVERY, PROCESSING AND PACKAGING WERE PERFORMED USING ASEPTIC TECHNIQUES. THIS PRODUCT IS INTENDED FOR USE IN ONE PATIENT ON A SINGLE OCCASION ONLY.
DESCRIPTION AND INDICATION FOR USE
ViBone® is a human tissue allograft consisting of cryopreserved bone matrix that is aseptically processed to preserve native factors that support bone repair. ViBone® is a Human Cellular and Tissue Based Product (HCT/P) per 21 CFR Part 1271. Each allograft is restricted to homologous use for transplant in procedures on a single occasion by a licensed physician or surgeon.
DONOR SCREENING AND TESTING (SUMMARY OF RECORDS)
ViBone® was prepared from a donor determined to be eligible by the Medical
Director of Aziyo or physician designee based on the results of screening and
testing. Donors are screened for high risk behavior and contraindications to
transplant through medical/social history interview, review of medical
records, physical assessment, and review of post mortem-examination results
(when applicable). Tissue from this donor has passed bacteriological testing
by a CUA Certified Laboratory. Communicable disease testing was performed by a
laboratory registered with FDA to perform donor testing and certified to
perform such testing on human specimens in accordance with the Clinical
Laboratory Improvement Amendments of 1988 (CUA) and 42 CFR part 493, or that
has met equivalent requirements as determined by the Centers for Medicare and
Medicaid Services (CMS) and found to be negative or non- reactive for a
minimum of:
- HIV type 1 and 2 antibody (HIV-1 & 2 Ab)
- HIV type 1 nucleic acid test using PCR and/or TMA format (HIV-1 NAT)
- Hepatitis B virus (HBsAg and HBV NAT)
- Hepatitis B core antibody total (HBcAb lgG/lgM or total)
- Hepatitis C virus (HCV Ab and HCV NAT)
- Syphilis by rapid plasma reagin (RPR) or other serological tests
Additional tests, including Human T-lymphotropic virus 1/11, may have been performed at the time of screening, and results were found acceptable for transplantation. Any additional test(s) performed can be provided upon request. Donor eligibility determination was made by Aziyo Biologics in compliance with U.S. FDA regulations (21 CFR 1270 and 1271) and American Association of Tissue Banks® (AA TB®) Standards.
WARNINGS AND PRECAUTIONS
An allograft may not elicit proper response from the recipient (e.g.
fusion/union with adjacent tissue). It is possible for a host site to become
infected or the allograft may cause an inflammatory response. Current
technologies may not preclude the transmission of infectious agents or
disease, including hepatitis and HIV.
ViBone® is preserved in 5% dimethyl sulfoxide (DMSO) in a 0.9% sodium chloride
solution. Povidone iodine, Dulbecco’s phosphate buffered saline, sodium
phosphate, hydrochloric acid and hydrogen peroxide are all used for
processing, preservation and storage of the allografts and trace amounts of
these solutions may be present in the product.
TRANSPORTATION, STORAGE AND HANDLING
ViBone® is supplied ready to use and must be stored in its original packaging
at -75°C (-103°F) or colder until prepared for use. It is the responsibility
of the transplant facility or clinician to maintain the allograft intended for
transplantation in the appropriate recommended storage conditions prior to
transplant.
HOW SUPPLIED.
ViBone® bone allograft is supplied frozen and packaged in a sterile
polycarbonate jar placed in a sterile outer peel pouch. The exterior surface
of peel pouch is not sterile. Allograft volume is indicated on the package
label.
STERILITY CONTROL
ViBone® allografts have been processed under aseptic conditions to prevent
contamination and cross contamination of the product. Destructive
microbiological testing per USP <71> Sterility Tests is performed on samples
from each lot and must show “No Growth” after a 14–day incubation in growth
promoting media.
PRECAUTIONS
Inspect the integrity of the package upon receipt and before use. Do not use
ViBone® under the following conditions:
- The container in which the allograft is stored is damaged or the label has been damaged or defaced.
- The allograft expiration date has passed.
- Recommended storage conditions have not been maintained.
INSTRUCTIONS FOR USE
It is important to utilize aseptic techniques when unpacking the allograft.
- Examine the labeling and outer peel pouch. Do not use if there is evidence that the integrity of the outer pouch has been compromised.
- Aseptically present the inner jar onto a sterile field.
- Don sterile surgical gloves; place the unopened jar into a sterile basin and fill with warm (approximately 37°C) sterile saline to just below the jar lid. DO NOT submerge the jar lid.
- Thaw ViBone® for approximately 5-15 minutes, depending on allograft size.
- Remove the jar lid and remove the product from the jar.
- The allograft tissue should be pliable. If the allograft is still frozen, warm by holding the allograft with sterile gloved hands until completely thawed and pliable.
- ViBone® should be transplanted within two hours of thawing and all unused product must be discarded. Product is intended for single use and should not be refrozen or sterilized.
TRACEABILITY
The FDA requires traceability from the donor to the recipient. The physician
is responsible for completing the recipient records to ensure traceability. As
a convenience, pre-printed peel-off labels are included with each allografl.
Using the labels, record the allograft tissue identification information in
the patient medical record. In addition, an Allograft Usage Report is included
with the allografl. The physician is to complete the report and affix one of
the pre-printed labels to it. Scan and email the completed report to
AllograftUsage@Aziyo.com.
ADVERSE REACTION
The physician must promptly report any adverse outcomes potentially
attributable to ViBone® to Aziyo at
800-922-3100.
Manufactured By:
- Aziyo Biologics, Inc.
- 880 Harbour Way S, Suite 100 Richmond, CA 94804
- Phone: 800-922-3100
- Fax: 510-307-9896
FDA Registration No. 1000100754
CTO Registration Certificate No. 100242
Accredited by the AA TB®·
Aziyo® and ViBone® are registered trademarks of Aziyo Biologics, Inc.
American Association of Tissue Banks® and AA TB® are registered service marks
of the American Association of Tissue Banks®·